Non-sterile convenience kits: Medline Open Heart CDS recall: Sterility Concern
Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD…
Why was Non-sterile convenience kits: Medline Open Heart CDS recalled?
Surgical convenience kits containing Pure Pouch component that has weak seals which may result in a breach in sterility of the contents if the seal fails.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Pack #CDS981759C - Lot numbers 24ADA460, exp. 7/31/2025; 23KDB724, exp. 7/31/2025; 23JDA205, exp. 10/31/2025; 23IDA683, exp. 11/30/2025; and 23EDA124, exp. 5/31/2025; UDI-DI each-10888277524002 and UDI-DI case-5/31/2025.
- Product
- Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kelly Forceps/STD…
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 7,673 total non-sterile kits
- Distribution
- US Nationwide distribution in the states of AL, CA, CO, CT, FL, IL, IN, MD, MN, MT, NC, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA, WI, and WY.
- Recall date
- July 10, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)